Senior Director Quality

Il y a 3 mois

Wavre, Belgique GSK Temps plein

**Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Italy - Siena, Spain - Madrid
**Posted Date**: Sep 1 2024

**Senior Director, Quality & Risk Management, Global Health**:
**The deadline for the job posting is the 15th of September**:
**Background**:
Global Health (GH) is a cornerstone of GSK’s ESG agenda, committed to change the trajectory of high burden diseases in lower-income countries with a focus on prevention and treatment of infectious diseases - We are investing £1bn over ten years to accelerate global health R&D.

The Global Health ambition is achieved through:

- R&D Developing new vaccines & medicines against high burden infectious diseases in lower-income countries
- Access Pursuing equitable access to GSK’s portfolio & pipeline
- Health System Strengthening Improve health equity for communities who need it most, through catalytic partnerships

**Purpose**:
The Senior Director, Quality & Risk Management, Global Health partners with the Global Health Leadership team to develop and deliver an effective Quality & Risk Management Program for the Global Health Unit in GSK

**Responsibilities include**:

- ** Partner with the GH LT to enhance the quality and compliance performance**, identifying and managing the inherent and emerging risks associated with the GH Strategy. This requires an understanding of the current level of control within the GH business lines and an understanding of the GH business activities
- ** Partner with GH Line Leaders to understand and enhance the risk and quality culture** so people at all levels of the organization, speak up when concerns, risks or issues occur. Allowing GH to proactively address matters through early mitigation using data to support changes in their Line operations
- Where appropriate, **integrate GSK and R&D quality, compliance and risk management policies and programs** into the GH business processes and ways of working. Bridge the full GSK enterprise approach to risk and quality management within GH Lines
- ** Develops and maintain a systematic quality risk management program** within the GH lines and at the enterprise level for multiple areas of regulatory risk, including Good Manufacturing Practices, Good Laboratory Practices, Human Biological Samples, Data Integrity, Anti Bribery and Corruption, Data Privacy and Ethical Treatment of Animals, Scientific and Patient Engagement, Human Subject Research as well as interactions with external parties of interest - Regulatory Authorities, CROs, AROs study sites and external partners. This is built through a strong collaborative GH RM Community of practice
- ** Provide objective leadership for GH** on matters arising (planned and unplanned); ensuring that GH’s ‘requirements, needs and interests’ are delivered. This may include and not be limited to leading the GH Grants and Donations Committee (in support of the non-R&D GH requests)
- ** Embed quality decision making into GH ways of working**, ensuring that the Internal Control Framework is integrated and compliant to corporate and regulatory standards by building strong partnerships across the network
- ** Maintain contemporary knowledge** in the evolving regulatory expectations and global environment that impact the business to proactively manage risks and increase the robustness of our business processes and decision making
- ** Outputs are deliverables will encompass the expectations of the Internal Control Framework**, for example:

- Training: Developing and identifying capability gaps to embed a robust quality and compliance training curriculum
- Risk Assessment: Overseeing the prioritization and escalation of GH line related risks to the GH LT and overseeing the definition and mitigation of GH Enterprise risks
- Management Monitoring: Ensuring a robust management monitoring across GH
- Responding to Problems: Agile problem solving as matters arise in GH
- Communication: Providing an enterprise monitoring perspective of the GH Enterprise Quality and Compliance performance; taking into the performance of business partners (to understand dependencies and impact on GH); through assessment of risk, compliance, and quality trends, facilitate implementation of quality improvements and ensure business critical quality improvements are adequately resourced to deliver. Utilize the learning to help GH drive proactive risk management
- GH Audit readiness, protecting the license to operate

**Requirements**:

- Bachelors’ Degree from a Global Health, Scientific, or related discipline
- A broad scientific/pharmaceutical industry background
- Knowledge of essential regulatory guidelines, world-wide policies and procedures which impact critical aspects of GH e.g. knowledge ABAC, Sanction, Human Subject Research, Scientific and Patient Engagement
- Demonstrated experience managing and engaging with senior stakeholders, peers, and teams
- Experience working and influencing in a cross functional, matrix environment
- Proven ability to manage

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